Industry News
drone delivery
Oct 18, 2023

Amazon will soon make prescription drugs fall from the sky when the e-commerce giant becomes the latest company to test drone deliveries for medications.

The company said Wednesday that customers in College Station, Texas, can now get prescriptions delivered by a 

The drone, programmed to fly from a delivery center with a secure pharmacy, will travel to the customer’s address, descend to a height of about four meters — or 13 feet — and drop a padded package.

Amazon says customers will be able to choose from more than 500 medications, a list that includes common treatments for conditions like the flu or pneumonia, but not controlled substances.

The company's Prime Air division began testing drone deliveries of common household items last December in College Station and Lockeford, California. Amazon spokesperson Jessica Bardoulas said the company has made thousands of deliveries since launching the service, and is expanding it to include prescriptions based in part on customer requests.

Amazon Prime already delivers some medications from the company’s pharmacy inside of two days. But pharmacy Vice President John Love said that doesn’t help someone with an acute illness like the flu.

“What we’re trying to do is figure out how can we bend the curve on speed,” he said.

Amazon Pharmacy Chief Medical Officer Dr. Vin Gupta says the U.S. health care system generally struggles with diagnosing and treating patients quickly for acute illnesses, something that was apparent throughout the COVID-19 pandemic.

Narrowing the window between diagnosis and treating makes many treatments more effective, he said.

Amazon is not the first company to explore prescription deliveries by drone. The drugstore chain CVS Health worked with UPS to test deliveries in 2019 in North Carolina but that program has ended, a CVS spokesman said.

Intermountain Health started providing drone deliveries of prescriptions in 2021 in the Salt Lake City area and has been expanding the program, according to Daniel Duersch, supply chain director for the health care system. Intermountain is partnering with the logistics company Zipline to use drones that drop packages by parachute.

Companies seeking to use drones for commercial purposes have faced hurdles from regulators who want to make sure things are operating safely. Amazon founder Jeff Bezos had predicted a decade ago that drones would be making deliveries by 2018. Even now, the e-commerce giant is only using the technology in two markets.

Lisa Ellman, the executive director of the Commercial Drone Alliance, an industry group that counts Amazon as one of its members, said to date, regulatory approvals have been limited to specific geographic areas and “in terms of their scope and usefulness to companies.”

That said, she noted regulators have also been issuing more approvals. Last month, the FAA gave the OK for Zipline and UPS to fly longer-range drones.

Walmart has also been working to expand its own drone deliveries.

Amazon says its drones will fly as high as 120 meters, or nearly 400 feet, before slowly descending when they reach the customer’s home. The done will check to make sure the delivery zone is clear of pets, children or any other obstructions before dropping the package on a delivery marker.

The company said it hopes to expand the program to other markets, but it has no time frame for that.

Amazon has been growing its presence in health care for a few years now.

Aside from adding a pharmacy, it also spent nearly $4 billion to buy primary care provider One Medical. In August, the company added video telemedicine visits in all 50 states.

fees
Oct 16, 2023

ORLANDO, FL – The National Community Pharmacists Association on Sunday announced a major new legal initiative for pharmacies that have been victimized by the unconscionable behavior of the largest pharmacy benefit managers that NCPA says have made billions in back-end penalties in violation of the law.

“PBMs shouldn't be able to make assessing junk DIR fees against competing pharmacies a multi-billion dollar cottage industry that puts their competition out of business and compromises patient care,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “It’s completely anti-competitive, and we’re fighting back.”

NCPA is creating a limited liability company, called TRUST LLC, which will investigate and, when appropriate, litigate or arbitrate on behalf of community pharmacies to recover coerced price concessions, otherwise known as pharmacy direct and indirect remuneration fees. NCPA believes DIR fees were assessed by the PBMs and insurance plans in violation of federal antitrust law and state contract laws. It’s the second major legal effort announced in the past several weeks. In September, the group applauded a class-action lawsuit against CVS Health, CVS Caremark, and Aetna brought by an independent pharmacist from Iowa who is also a member of NCPA.

“These companies have nearly unlimited resources and it’s almost impossible for a single independent pharmacy to fight them alone. The way the contracts are set up, arbitration for claims like these can top $1,000,000 for a single pharmacy. NCPA’s efforts allow independent pharmacies to assign their claims to TRUST LLC to fight the PBMs together,” said Hoey. “It’s still not an even playing field, but we have a much better chance of getting justice if we join forces.”

TRUST LLC has retained the law firms of Berger Montague PC, Cohen & Gresser LLP, and Baker Donelson to lead the litigation. Berger Montague and Cohen & Gresser are the firms that filed the class-action lawsuit against CVS Health in federal court last month.

“Community pharmacists are indispensable providers of health care in communities across the United States,” said Katie Funk, a partner with Baker Donelson. “We look forward to working with NCPA to expose the unconscionable PBM practices that are driving up costs, eliminating patient choice, and driving community pharmacies out of business.”

NCPA made the announcement at its annual convention, this year taking place in Orlando, Fla. To learn more about the TRUST, please visit www.fightPBMs.com.

IT conference collaboration
Oct 16, 2023

ORLANDO, FL – HIMSS Global Health Conference & Exhibition and Health Connect Partners are thrilled to announce the launch of a highly anticipated Hosted Buyer Program at the HIMSS24 event in Orlando. This innovative initiative is set to elevate the attendee and exhibitor experience to new heights, offering unparalleled opportunities for networking, collaboration, and business development within the dynamic healthcare technology sector.

HIMSS24, scheduled to take place March 11-15, in Orlando, is the most prestigious gathering in healthcare IT, attracting over 33,000 professionals and thought leaders from around the world who are creating tomorrow’s health. This year, the introduction of the Hosted Buyer Program aims to facilitate focused meetings between providers looking for solutions and the most innovative and trusted companies in healthcare IT.

The Hosted Buyer Program offers a unique platform for healthcare providers and other key decision-makers to connect with leading solution providers and technology innovators in a curated and productive environment. Participants in this program will benefit from:

Exclusive Matchmaking: HIMSS24 is partnering with Health Connect Partners to pair select buyers with exhibitors who align with their specific interests, ensuring the most productive conversations and meaningful interactions.

VIP Access: Hosted buyers will enjoy VIP treatment, including expedited registration, access to an exclusive Hosted Buyers area on the show floor with dedicated concierge services

Time Management: A series of focused, one-on-one meetings

Curated Exploration: By participating in pre-scheduled one-on-one meetings with top information and technology suppliers, hosted buyers can explore potential partnerships to improve patient experience, new technologies and more

"We are excited to introduce the Hosted Buyer Program at HIMSS24 in collaboration with Health Connect Partners, as it represents a significant leap forward in our efforts to connect executive buyers with the latest advancements in healthcare technology," said Elli Riley, Vice President, HIMSS Global Health Conference & Exhibition. "This program is designed to foster collaboration, connection, and business growth at HIMSS24."

David Mason, Founder and CEO of Health Connect Partners added, “We are pleased to partner with HIMSS Global Health Conference & Exhibition to manage the Hosted Buyer program. We have been conducting Hosted Buyer events since our inception in 2006 and have served the Hospital IT market since 2011.  This is a great partnership, and we look forward to adding value to the already successful HIMSS Global event starting in March of 2024.”

Applications for the Hosted Buyer Program at HIMSS24 are now open. Apply for the program as part of your event registration. Interested healthcare professionals are encouraged to register and apply early to secure their spot in this exclusive program.

HIMSS24 exhibitors interested in participating in the Hosted Buyer Program should contact their account manager or email salesinfo@himss.org

Learn more about HIMSS24. Join the conversation on Twitter and LinkedIn with #HIMSS24 or by following @HIMSS

Cardinal Health Women Pharmacists
Oct 12, 2023

The pharmacy profession has become increasingly dominated by women over the past decade. Since 2012, women have accounted for more than half of the U.S. pharmacy workforce, according to Zippia, an online recruitment services company. Women pharmacists occupy nearly 60% of management positions, according to the American Association of Colleges of Pharmacy (AACP). Data from AACP also shows that this trend is expected to continue – women represented two-thirds of all students enrolling in pharmacy school in the fall of 2022.

Yet, despite the ground women have gained in the pharmacy field, they are still underrepresented in pharmacy ownership. Women own only 25% of independent pharmacies, according to the AACP’s National Pharmacy Workforce Study. As the role of the pharmacist continues to expand and patient demand for clinical services increases, Cardinal Health is working to empower the next generation of women pharmacy owners.

On this Women in Pharmacy Day, we are highlighting a selection of the many pharmacists we have supported through our efforts to inspire future women pharmacy owners, empower women stepping into pharmacy leadership, and champion the women pharmacy leaders guiding the next generation.

Empowering women pharmacy owners in Puerto Rico

Five years ago, Cardinal Health Puerto Rico established a Women in Pharmacy chapter to support and develop the next generation of women pharmacy owners.

"The Puerto Rico Women in Pharmacy chapter works to foster connections and provide resources to women pharmacy school graduates,” said Carla Fernandez, SVP/GM of Cardinal Health Puerto Rico. “Each year, we host several events designed to inspire and motivate future pharmacists to embark on the ownership journey. We established an annual forum for members and each year, we manage to impact and influence more people.”

Chapter programming focuses on education, networking and best-practice sharing. The organization also connects women pharmacy school graduates with a supportive network of peers to guide them on the path to ownership.

While the School of Pharmacy Puerto Rico reports that 66% of pharmacy school graduates in Puerto Rico are women, purchasing group data shows that women represent only 45% of independent pharmacy owners. Retail independent pharmacies are prevalent in Puerto Rico, with nearly 850 locations generating more than 14,000 jobs, according to a report from the Puerto Rico Community Pharmacies Association ­– indicating plenty of opportunity to increase the number of women who own pharmacies. 

"At Cardinal Health, we want to develop a new generation of women business owners to manage healthcare on our island," said Michelle Montalvo, VP of Pharmaceutical Sales & Marketing, Puerto Rico, who serves as the sponsor for the Puerto Rico Women in Pharmacy chapter.

In August 2023, the chapter hosted a highly successful event during the College of Pharmacy of Puerto Rico’s annual convention, with more than 250 attendees. Thirty-three of the attendees expressed interest in purchasing a community pharmacy within the next three years.

Lifting up “rookies” and offering support

Each year, Medicine Shoppe International, Inc., a Cardinal Health company, presents the Rookie of the Year award to new franchisees who have joined the system within the past 18-24 months and have demonstrated a commitment to becoming a healthcare destination for families and communities. This year’s recipient, Jennifer Seltzer, PharmD, made the transition from Pharmacist-in-Charge at The Medicine Shoppe® Pharmacy in Bloomsburg, Pennsylvania, to owner in 2022.

“I decided that I wanted to transition to become an owner at least 10 years ago. I had been working toward it mentally for years,” said Seltzer. “I am not a risk taker, so it took encouragement from my husband and my girls (ages 10 and 12), who help out at the pharmacy where they can. They were completely on board with having a part of something we could really call our own and something that would support the community.”

When it came time for the transition to ownership, Seltzer said that having the support of her Cardinal Health Franchise Business Consultant, Rich Townsend, as well as support from Cardinal Health™ Pharmacy Transition Services made the process easier. Through Cardinal Health, Seltzer also gained access to networking opportunities that helped her form meaningful mentorships with other pharmacy owners.

“The Cardinal Health team helped answer all my questions and facilitate the big things that needed to happen to make the transition,” she said. “They were able to connect me with the key people I needed to have conversations with.”

Seltzer’s advice to other women seeking to become pharmacy owners is to recognize the opportunities and guidance available to them.

“I would encourage them to move towards ownership and know that we live in a time where there are a ton of resources out there. With support from the Cardinal Health transition team and others in the company, there will be people there to help you. I hope someday there are more women pharmacy owners because we’re very good at what we do,” Seltzer said.

After the first year and a half of ownership, Seltzer continues to add more and more services, including compounding, compliance packaging, durable medical equipment, COVID-19 vaccines and testing, and prescription delivery. She sees herself continuing to expand the services she offers well into the future.

“I’m always looking for the next thing that will help independent pharmacy. Some of the most successful pharmacists I know – men and women – that’s how they operate as well. Twenty years from now, I’ll still be here sitting at my desk, looking for the next thing in independent pharmacy,” she said.

Providing opportunities for the next generation

Recognizing the achievements of today’s women pharmacy leaders can help to inspire the next generation. Research published by the Review of General Psychology shows that having a woman as a role model can help expand the perception of what is possible, inspire women to be more ambitious, and demonstrate the mindset and behaviors that can help women advance.

Brandi Ollerman, PharmD, owner of The Medicine Shoppe® Pharmacy in Dickinson, North Dakota, serves as a role model for those entering the pharmacy field in her community, and has developed a successful training program to help young students – men and women.  

“I am a mom, a wife, pharmacist and pharmacy owner,” said Ollerman. “Leading by example, my hope is that I will encourage and inspire other young women interested in pharmacy to take the leap into this rewarding career and maybe even become pharmacy owners themselves someday.”

When approached about having local students come to her pharmacy to learn about the industry, Ollerman saw an opportunity to both support the next generation of pharmacists and address her need for pharmacy technicians.

After students shadowed her staff at the pharmacy, Ollerman took the opportunity a step further by reaching out to local schools offering Pharmacy Technician certifications. She partnered with an interested teacher to establish a pharmacy technician education program. Ollerman sought out necessary authorization from the State Board of Pharmacy and worked with local schools to ensure students could receive class credit. Rallying together her community, schools and local leaders, Ollerman has established pharmacy technician training partnerships with area high schools, trade schools and state programs. This year, the program has expanded to two additional pharmacies, adding two more students at locations in Southwestern North Dakota.

“The program helped to address previous staffing challenges at The Medicine Shoppe® Pharmacy and gives students experience working in the pharmacy. It provides an alternative to the traditional four-year degree and gives the students a stepping stone into pharmacy school or an opportunity to have a fulfilling career as a pharmacy technician,” Ollerman said. “We love to share our love of pharmacy, and whether they stay and work as a technician or continue their education to become a pharmacist, it is a win-win for us.”

In May 2022, one of the first students to come through the program earned her pharmacy technician certification. The student has enrolled in pharmacy school and still comes back to help out when she is visiting on school breaks. Another pharmacy student received her certificate in May 2023.

“Working beside our staff, sharing decision making and including them in day-to-day activities allows students to have an inside view of pharmacy, as well as the work-family balancing act – the good, the great and the chaos,” said Ollerman. “They see the relationships created with patients and staff and they can start creating their own experiences and building those relationships.”

Across the U.S., women pharmacists and healthcare leaders are working together to provide education, networking, support, and opportunities that open pathways to ownership and future careers in pharmacy. Cardinal Health is proud to recognize the outstanding work these women are doing – on Women in Pharmacy Day, and every other day of the year. 

 

This story was originally published on the Cardinal Health Newsroom.

Biosimilars
Oct 12, 2023

BRIDGEWATER, NJ - Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the addition of two denosumab biosimilars referencing both Prolia® and XGEVA® to its biosimilar pipeline.

Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries.

The two denosumab products are being developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Under the terms of the agreement, mAbxience will fully develop the biosimilar molecule and manufacture it in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience also currently partner on ALYMSYS®, a bevacizumab biosimilar.

“Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high quality, essential therapies,” said Harsher Singh, Senior Vice President, Amneal Biosciences. “Our first three commercial U.S. biosimilars are doing very well as our excellent commercial team drives uptake in these competitive categories. We are pleased to partner again with mAbxience on these next two biosimilar candidates, which deepens our pipeline and expands our presence in oncology.”

“We are thrilled to strengthen our partnership with Amneal through this second agreement, marking a significant step forward in our shared mission to enhance global health. This collaboration will bring two world-class biosimilars for the treatment of bone diseases and oncology to patients across the U.S., reinforcing our commitment to ensuring worldwide access to high-quality, life-enhancing treatments. Together with Amneal, we continue to make strides in offering affordable and accessible healthcare solutions, contributing positively to public health and solidifying our presence in the global biosimilar space,” said Emmanuelle Lepine, Chief Executive Officer, mAbxience.

According to IQVIA®, U.S. annual sales for Prolia® and XGEVA® for the 12 months ended August 2023 were approximately $4.4 billion.

The financial terms of the transaction were not disclosed, and any incremental expenses associated with these products are contemplated within Amneal’s guidance.

Danielle Griggs UVA Health
Oct 11, 2023

UVA Health has promoted Danielle Griggs, PharmD, MBA, MS, to serve as the health system’s next chief pharmacy officer. A UVA Health team member since 2016, Griggs will oversee pharmacy services across all four of the health system’s medical centers in Charlottesville, Culpeper, Haymarket and Prince William.

Selected for her new role after a national search, Griggs will lead more than 500 frontline pharmacy team members in providing critical medications for patients across Virginia.

“Our pharmacy team is critical to the goal in our 10-year strategic plan of delivering care close to home for all Virginians with complex health needs,” said Min Lee, chief operating officer for UVA Health University Medical Center. “Whether being a persistent advocate for our pharmacy team in support of stellar operations or working tirelessly in pursuit of our mission to achieve outstanding outcomes in research, education and clinical care, Danielle is committed to inspiring ideas from our frontline team that will ensure the best service for our patients and communities, while remaining a premier pharmacy operation.”

Griggs has held a variety of roles at UVA Health, beginning as a pharmacy manager, where she was responsible for health system medication procurement and drug expense management. She went on to oversee the medication formulary, clinical and operational programs, drug shortages, and 340B operations and compliance. In 2019, Griggs was promoted to serve as senior director of pharmacy, where she has been responsible for pharmacy business operations across the health system.

“Over the past seven years, I have seen firsthand what a tremendous pharmacy team we have here at UVA Health, and I am honored to have been chosen to lead it,” Griggs said. “I look forward to continuing to work alongside our excellent team to provide high-quality care and service for all of our patients.”

Griggs received her doctor of pharmacy and master’s in business administration from the University of Kentucky. She also completed a residency in health system pharmacy administration at the University of North Carolina at Chapel Hill, where she also earned her master of science degree from the Eshelman School of Pharmacy.

Bayer
Oct 10, 2023

BERKELEY, CA - Bayer AG announced today the opening of its first Cell Therapy Launch Facility in Berkeley, California to create the capacity to bring cell therapies to patients on a global scale. The $250 million (USD), 100,000-square-foot facility will supply the material required for late-stage clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson’s disease. In addition, it includes space for a second module of production suites to support additional cell therapies as Bayer’s portfolio advances. BlueRock Therapeutics LP is a clinical stage, cell therapy company and wholly owned, independently operated subsidiary of Bayer AG.

“Cell therapy represent a groundbreaking class of medicines and is an area where Bayer is making a significant investment to research potentially transformative treatment approaches for people with unmet medical needs,” said Sebastian Guth, President of Bayer U.S.A. and Pharmaceuticals North America, and member of the Pharmaceutical Executive Committee. “Our new cell therapy facility represents true innovation in product development and manufacturing in addition to contributing to Bayer’s sustainability goal as our first fully electric pharmaceutical manufacturing plant.”

The new Cell Therapy Launch Facility is part of a transformation at the company’s dedicated biotechnology site in Berkeley, where Bayer has invested nearly USD 500 million in infrastructure over the past five years.

“Our teams are driving innovation in late-stage development and manufacturing with a goal of bringing transformational cell and gene therapies to patients on a global scale, and this facility will enable us to make it real,” said Jens Vogel, Sr. Vice President and Global Head of Biotech for Bayer’s Pharmaceutical Division. “Bayer is collaborating with biotech innovators, academia, and equipment and automation suppliers to establish platforms that would help bring more therapies to patients faster.”

Bayer’s global biotech organization recognizes the importance of helping innovators transfer their product candidates from the laboratory bench to the clinical study and commercial launch settings. The Biotech team provides its biologic development and manufacturing capabilities for Bayer’s larger biotherapeutics portfolio, including commercial products and late-stage protein and cell therapies in development. As part of Bayer’s larger mission of “Health for All,” the company is now also helping early-stage U.S. and European companies to enable patient trials and commercial launches through its BioPartnering Solutions offerings.

“Having access to this Cell Therapy Launch Facility is central to our goal to deliver impactful cell therapies from our pipeline to patients in need,” said Seth Ettenberg, President & CEO of BlueRock Therapeutics. “Our team is excited to be working shoulder to shoulder with Bayer’s biotech scientists and manufacturing experts as we look to scale up manufacturing for our first investigational therapy, bemdaneprocel for Parkinson’s disease, as it advances through clinical trials.”

The new Cell Therapy Launch Facility, launched in conjunction with manufacturing day in the United States, is among several recent investments to advance Bayer’s biologic pipeline of protein therapeutics, cell and gene therapies including a new Cell Culture Technology Center and Cell Therapy Labs. The new Cell Therapy Launch Facility features flexible, modular space for cell culture, viral transduction and automated filling of cell therapies leveraging Biotech@Bayer expertise in iPSC and CAR-T characterization, process development, analytics and clinical to commercial production.

Beyond Berkeley, the company’s global biotech network includes biologic development, manufacturing science, industrialization and advanced manufacturing engineering teams in Wuppertal and Leverkusen, Germany; and Basel, Switzerland; with a full complement of labs and clinical production suites.

About bemdaneprocel and Parkinson’s Disease

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from pluripotent stem cells (PSC) that are human embryonic stem cells. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to reform neural networks that have been severely affected by Parkinson’s and restore motor and non-motor function to patients. Planning is underway for BlueRock Therapeutics’ Phase II study that is expected to begin enrolling participants in H1 (first half) 2024.

Parkinson’s disease is a progressive neurodegenerative disorder caused by the death of nerve cells in the brain, leading to decreased dopamine levels. At diagnosis, it is estimated that patients have already lost 50-80% of their dopaminergic neurons. The loss of these neurons leads to a progressive loss of motor function and symptoms such as tremors, muscle rigidity, and slowness of movement. Even with medication, the symptoms of Parkinson’s disease can fluctuate during the course of the day. According to the Parkinson’s Foundation, more than 10 million people worldwide suffer from Parkinson’s disease, with approximately one million living in the United States. There is no cure, and the effectiveness of current treatments decreases over time.

About BioPartnering Solutions for Biotech Innovators in U.S. and Europe

Through Bayer’s BioPartnering Solutions, innovators can leverage industry-leading biotech process development and biomanufacturing capabilities to make their therapeutic candidates a reality. Bayer’s highly skilled Biotech teams and infrastructure – which includes preclinical, clinical and commercial launch scale manufacturing – are available to advance promising cell therapy, monoclonal antibody and protein therapeutic candidates from the discovery bench to patients. Through BioPartnering Solutions, Bayer provides early-stage companies with a single source of IND- and BLA-enabling development; bioprocess and biochemical engineering; clinical and commercial manufacturing. A range of complementing support service functions such as supply chain management, procurement, quality, and CMC strategy support for regulatory filings are also available. For more information visit: https://www.bayer.com/en/us/BioPartneringSolutions.

Clinical trials
Oct 10, 2023

NEW HAVEN, CT. - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company's investigational oral innate immune activator, in combination with KEYTRUDA® (pembrolizumab) in patients with small cell neuroendocrine prostate cancer (SCNC). As of a data cutoff of September 6, 2023, evaluable patients with SCNC (n=28) showed a median OS of 13.6 months (95% CI 10.9–NR), and a 12-month survival rate of 56.5%.

“OS is the most meaningful measure by which the effectiveness of an oncology treatment is evaluated. Though these results are based on a non-randomized cohort of patients, observing a median OS of this duration including patients with long-term survival at 12 months and beyond shows exceptional promise, bearing in mind historic data with checkpoint inhibitor monotherapy in this high-risk subset of prostate cancer,” said Rahul Aggarwal, M.D., Principal Investigator, Associate Director for Clinical Sciences, Helen Diller Family Comprehensive Cancer Center, and Professor of Medicine at the University of California San Francisco (UCSF). “SCNC represents a major unmet medical need, with the majority of patients unfortunately succumbing to their disease in less than one year following chemotherapy. The results of this trial suggest that BXCL701 has the potential to extend the lives of patients, and I look forward to its continued clinical development.”

SCNC, classified as a “cold” tumor, represents an underserved, growing patient population, with cases increasing due to earlier and more widespread use of androgen receptor inhibitors. In 2023, there will be an estimated 288,3002 new patients with prostate cancer in the United States, with approximately 11,532 patients progressing to SCNC.

“We believe our trial results are highly encouraging for patients with this disease and have potential implications for our evaluation of BXCL701 for the treatment of other high-grade neuroendocrine tumors, such as small cell lung cancer, where effective therapies are lacking,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “We intend to discuss these data with the FDA to help determine our next steps with clinical development.”

The Phase 2 trial is an open-label, multicenter study to evaluate the safety and efficacy of BXCL701 in combination with pembrolizumab in men with SCNC. Twenty-eight (28) evaluable SCNC patients received 0.3 mg of BXCL701 twice daily (BID) on days 1 through 14 of a 21-day cycle (0.2 mg BID the first week of cycle 1) plus 200 mg of pembrolizumab administered intravenously on day 1 and every subsequent 21 days. The primary objective of the trial is a composite response rate defined as either objective response by RECIST 1.1 criteria and/or PSA50 and/or CTC count conversion.
Secondary objectives include duration of response, progression-free survival, overall survival, and biomarker evaluation as measured by changes in circulating cytokines and correlation of outcome with baseline tumor characteristics.

The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A.

Conference Call
BioXcel Therapeutics will host a conference call and webcast on October 10, 2023 at 8:00 a.m. ET to discuss the data results from the Phase 2 trial of BXCL701. To access the call, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A live webcast and presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a webcast replay will be available through January 10, 2024.

Parkinson's
Oct 06, 2023

NORTH CHICAGO, IL - AbbVie (NYSE: ABBV) announced today that it has exercised its exclusive right and completed the acquisition of Mitokinin, a discovery-stage biotechnology company developing a potentially first-in-class disease-modifying treatment for Parkinson's Disease (PD). Mitokinin's lead compound, a selective PINK1 activator, is designed to address mitochondrial dysfunction that is believed to be a major contributing factor to Parkinson's disease pathogenesis and progression.

PINK1 plays a key role in maintaining a healthy mitochondrial system by facilitating the turnover of dysfunctional mitochondria. Mutations in PINK1 are associated with a loss of PINK1 function and cause familial forms of PD. Activation of PINK1 offers a potentially disease-modifying treatment approach beyond familial PD, by addressing mitochondrial dysfunction and improving mitochondrial health in sporadic PD.

"Parkinson's disease continues to be a major unmet medical need, impacting patients, caregivers and society. With this acquisition, we are excited to grow our neuroscience portfolio and explore a potential new treatment option for PD," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. "While current PD treatments may alleviate the symptoms of parkinsonism, there are currently no available therapies that prevent progression of the disease. Targeting PINK1 offers a novel approach that may alter disease pathogenesis."

"Collaboration with AbbVie's world-class Neuroscience and External Innovation teams added significant value and resources to help accelerate the program to investigational new drug (IND) enabling studies," said Daniel de Roulet, co-founder and chief executive officer, Mitokinin.

The role of PINK1 in addressing mitochondrial dysfunction has long been recognized; however, developing selective, brain penetrant PINK1 activators for therapeutic use in PD has been challenging.

"Our pre-clinical data demonstrate that our PINK1 activator compound can selectively enhance the active-form of PINK1, which is found on damaged mitochondria, without impacting PINK-1 regulation broadly," said Nicholas Hertz, Ph.D., co-founder and chief scientific officer, Mitokinin. "We believe this approach could potentially deliver significant clinical benefit to Parkinson's patients."

Under the terms of the agreement, AbbVie will pay Mitokinin shareholders $110 million at closing for the acquisition of Mitokinin. Mitokinin shareholders remain eligible for potential additional payments of up to $545 million upon the achievement of certain development and commercial milestones related to the success of the PINK1 program, plus tiered royalties based on net sales.

Kaiser Permanente Facility
Oct 04, 2023

In a historic move, 75,000 healthcare workers at Kaiser Permanente facilities across the United States have gone on strike, demanding fair wages, better working conditions, and improved patient care. The strike is one of the largest labor actions in recent memory and has far-reaching implications for both healthcare workers and patients.

Reasons for the Strike

The Kaiser Permanente workers, including pharmacist, technicians, and support staff, have cited several key reasons for their strike action. At the forefront of their demands is a call for fair compensation. Workers argue that their wages have not kept pace with the rising cost of living, leaving many struggling to make ends meet. Union representatives assert that the strike is a last resort after failed negotiations with Kaiser Permanente management.

Additionally, healthcare workers are seeking improved staffing levels and working conditions. Overworked and understaffed hospitals and clinics have taken a toll on their ability to provide quality care to patients. The COVID-19 pandemic has only exacerbated these issues, pushing many healthcare professionals to their limits.

Impact on Patients

The strike has had a significant impact on patient care. With tens of thousands of healthcare workers walking off the job, Kaiser Permanente has been forced to cancel non-emergency procedures and reduce services in some areas. This has left many patients in need of vital medical care facing delays and uncertainty.

Kaiser Permanente has implemented contingency plans to minimize disruptions to patient care during the strike. They have brought in temporary replacement workers, but the situation remains challenging. Patients are facing longer wait times, and some have had to seek care at other facilities, putting additional strain on the healthcare system.

Potential Outcome of the Dispute

The outcome of this labor dispute could have far-reaching consequences for both the healthcare industry and the labor movement. As the strike continues, both sides are under pressure to reach a resolution that addresses the workers' concerns while ensuring the continuity of patient care.

If a fair agreement is reached, it could set a precedent for better wages and working conditions for healthcare workers across the country. The strike has already garnered significant public support, with many Americans recognizing the vital role these workers play in the healthcare system.

On the other hand, if the strike drags on without resolution, it could lead to further disruptions in patient care and could have negative implications for Kaiser Permanente's reputation. The longer the strike persists, the more challenging it will be for the healthcare provider to maintain its commitment to patient well-being.

The Kaiser Permanente workers' strike is a significant moment in the ongoing struggle for fair wages and better working conditions in the healthcare industry. As the strike continues, the eyes of the nation are on the negotiations between labor unions and management. The outcome of this dispute will not only impact the lives of the 75,000 workers involved but also the millions of patients who depend on Kaiser Permanente for their healthcare needs.